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Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Pharmaceutical
New York-based Mind Medicine, a company developing MM120, a form of LSD (lysergide d-tartrate), for mental health conditions, has announced the appointment of Gregg Pratt, as chief regulatory and quality assurance officer. 19 November 2024
Biotechnology
Last week saw US pharma major AbbVie release disappointing Phase II trial results on its emraclidine in schizophrenia, which benefited Bristol Myers Squibb. Also on the research front, Germany’s Merck KGaA and Abbisko’s pimicotinib showed positive results in tenosynovial giant cell tumor (TGCT). M&A news saw German BioNTech punting $800 million upfront to acquire China based oncology focused Biotheus. Also of note, US drugmaker Halozyme Therapeutics made an unsolicited takeover bid for Evotec, valuing the German firm, at around 2 billion euros. 17 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Biotechnology
Swiss clinical-stage biopharma AC Immune saw its shares gain 8% to $3.38 in US trading this morning, after it released positive interim safety and immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Pharmaceutical
Digital therapeutics company GAIA has announced the signing of a licensing agreement for attexis with fellow German firm MEDICE Arzneimittel Pütter. 14 November 2024
Biotechnology
Cambridge, USA-based Vesalius Therapeutics has entered into a multi-target strategic alliance with the UK’s GSK to discover and develop novel treatments for Parkinson's disease, and another undisclosed neurodegenerative indication. 13 November 2024
Biotechnology
Neurogene has announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase I/II open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. 13 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Pharmaceutical
US drug major Merck & Co has updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine. The drugmaker provided this update in conjunction with poster presentations of new data from two Phase III clinical studies of telcagepant at the 14th International Headache Congress. 11 September 2009
Pharmaceutical
Leading Israeli drugmaker Teva Pharmaceutical Industries says that that new research data furthering the clinical understanding of its diverse multiple sclerosis (MS) treatment franchise will be presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Dusseldorf, Germany, September 9-12, 2009. 9 September 2009
Pharmaceutical
Facet Biotech's board of directors has reviewed Biogen Idec's unsolicited acquisition offer, made ahead of last weekend (The Pharma Letter September 7) proposal and has concluded that it inadequate, noting that the bid of around $356 million is approximately the value of its cash, marketable securities and restricted cash. 9 September 2009
Pharmaceutical
Two potentially key genes linked to the development of Alzheimer‘s disease have been uncovered by UK researchers, reporting in the journal nature Genetics. It is the first gene clue to the condition in 16 years and has prompted scientists to rethink their theories on how the disease develops, said the UK 8 September 2009
Biotechnology
Facet Biotech Corp has confirmed that it is in receipt of fellow USA-based Biogen Idec 7 September 2009
Biotechnology
In response to the recent Fritz Beske Institute 7 September 2009
Biotechnology
A US District Court has sided with US biotechnology firm Biogen Idec regarding Irish drugmaker Elan 4 September 2009
Pharmaceutical
PTC Therapeutics in up to $1 billion discovery collaboration with Roche 3 September 2009
Pharmaceutical
In yet another Japanese bid to extend its reach into the all important US pharmaceutical market, drug major Dainippon Sumitomo has entered into an agreed transaction to acquire Sepracor for around $2.6 billion, or $23 a share, a 27.6% premium to the US firm 3 September 2009
Pharmaceutical
Global pharmaceutical behemoth Pfizer (which is in the process of acquiring fellow US drug major Wyeth in a $68 billion deal), and its subsidiary Pharmacia & Upjohn (acquired in 2003), have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the US Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Department announced on September 2. 3 September 2009
Pharmaceutical
The news that Alkermes has received notification from fellow USA-based health care major Johnson & Johnson 1 September 2009
Pharmaceutical
Turning serendipity into science, researchers at the Stanford University School of Medicine in the USA have found a link, in mice and in human brain tissue, between high blood pressure and multiple sclerosis. Their findings suggest that a safe, inexpensive drug already in wide use for high blood pressure may have therapeutic value in multiple sclerosis, as well. 19 August 2009
Generics
Although generic erosion will negatively impact the major depression drug market in the United States, patent protection of key blockbuster agents will help drive market growth in Europe and Japan through 2018, according to a new study from research and advisory firm Decision Resources. 18 August 2009
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Extavia (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease. 17 August 2009
Pharmaceutical
Swiss biotechnology firm Santhera Pharmaceuticals has entered into an agreement to gain rights to JP-1730/fipamezole from Finland-based Oy Juvantia Pharma, exercising its option to acquire the latter, through the issue of previously reserved shares from its authorized capital to Juvantia investors subject to certain conditions. Further financial details were not revealed. JP-1730/fipamezole, a first-in-class compound, recently completed Phase II development for the treatment of dyskinesia in Parkinson‘s disease. Klaus Schollmeier, chief executive of Santhera, said: "The positive FJORD Phase IIb results confirmed the efficacy of JP-1730/fipamezole in reducing levodopa-induced dyskinesia in patients suffering from Parkinson‘s disease. In order to exploit the full potential of the drug for Santhera, including potential out-licensing rights, we now have full access to all rights to the product." Upon the exercise of the option, Santhera Pharmaceuticals Holding AG immediately became the owner of Juvantia. In consideration and subject to certain conditions, Santhera will later issue up to 105,973 previously reserved shares from its authorized capital to Juvantia investors. The new shares will be listed on SIX Swiss Exchange. In July 2006, Santhera and Juvantia signed a collaboration agreement to advance the development of Juvantia‘s product. Under the deal, the Swiss firm was responsible for conducting and funding further development work. At the same time, a separate option agreement between Santhera and the Juvantia investors effectively granted Santhera the right to acquire Juvantia, thereby securing all rights to the program. 17 August 2009
Pharmaceutical
The US Food and Drug Administration has approved drug major Schering-Plough 17 August 2009
Pharmaceutical
Antipsychotic pipeline developers have been in the spotlight in recent weeks with the announcement of the US Food and Drug Administration 7 August 2009
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